The investigators aim to compare two antibiotic treatments for enteric (typhoid) fever. Three hundred patients at Patan Hospital will be enrolled in the study. Patients will be assigned to one of the two treatments by chance and followed for 6 months. The two treatment groups will be compared to see which treatment is more likely to make the patient better.

Further study details as provided by Oxford University Clinical Research Unit, Vietnam:

Primary Outcome Measures:

Rate of treatment failure [ Time Frame: upon occurance, within 28 days ] [ Designated as safety issue: No ]

Any one (1) of the following defines treatment failure:

Fever clearance time >7 x 24hours post treatment initiation

Blood culture positive at Day 8 of treatment (microbiological failure)

Requirement of rescue treatment

Culture confirmed or syndromic relapse within 28 days of initiation of treatment

The development on treatment of any enteric fever related complication within 28 days of initiation of treatment including, clinically significant bleeding, fall in the Glasgow Coma Score, perforation of the gastrointestinal tract or admission to hospital Both the absolute risk of treatment failure and the time to treatment failure will be analyzed

With the study hypothesis that Gatifloxacin is superior to Ceftriaxone in terms of treatment failure in patients with enteric fever, a comparative study will be conducted at Patan Hospital. 300 patients who are diagnosed with enteric fever will be enrolled into the study. The patients will be randomized to one of two groups. One group will receive treatment with Gatifloxacin for 7 days, and the other with Ceftriaxone. The patients will be followed during the treatment courses and at several points of 6 months after initial presentation. The endpoints then will be compared between two groups.

Eligibility

Ages Eligible for Study:

2 Years to 45 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Suspected or culture proven enteric fever

>= 2 <= 45 years of age

Fever >= 38°C for >= 4 days

Informed consent to participate in the study

Exclusion Criteria:

Pregnancy

Obtundation

Shock

Visible jaundice

Presence of signs of gastrointestinal bleeding

Evidence of severe disease

Diabetes

History of hypersensitivity to either of the trial drugs

Known previous treatment with a quinolone antibiotic or 3rd generation cephalosporin or macrolide within one week of hospital admission.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01421693